Roberto Bernardo-Escudero

Mexican Association for the Clinical Research

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Rosalba Alonso-Campero

Mexican Association for the Clinical Research

María Teresa de Jesús Francisco-Doce

Centro de Estudios Tecnológicos y Universitarios

Manuel Cortés‐Bonilla

Instituto Nacional de Perinatología

Juan Chavarín-González

Myriam Cortés-Fuentes

Centro Tecnológico del Mar

Peter Chedraui

Universidad de Especialidades Espíritu Santo

Lucía Zambrano-Tapia

Miriam Villa-Vargas

Centro Tecnológico del Mar

Shantal Pimentel-Martínez

JÁ

Juan Ángeles-Uribe

Centro Tecnológico del Mar

Cooperative Institutions

Bülent Ecevit University

Chinese University of Hong Kong

Prince of Wales Hospital

Centrum Onkologii

Mexican Social Security Institute

Nara Medical University

Nara Medical University Hospital

Collegium Medicum in Bydgoszcz

University of Turin

Northwestern University

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Comparison of the Pharmacokinetics of a New 15-mg Modified-Release Tablet Formulation of Metoclopramide Versus a 10-mg Immediate-Release Tablet: A Single- and Multiple-Dose, Randomized, Open-Label, Parallel-Group Study in Healthy Mexican Male Volunteers

Clinical Therapeutics (2011)

Roberto Bernardo-Escudero Rosalba Alonso-Campero María Teresa de Jesús Francisco-Doce Myriam Cortés-Fuentes Miriam Villa-Vargas

Metoclopramide

Tolerability

Bioequivalence

10.1016/j.clinthera.2011.04.016

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Citations (3)

Observational Study of the Local Tolerability of Injectable Progesterone Microspheres

Gynecologic and Obstetric Investigation (2011)

Roberto Bernardo-Escudero Manuel Cortés‐Bonilla Rosalba Alonso-Campero María Teresa de Jesús Francisco-Doce Juan Chavarín-González

Background: As intramuscular progesterone administration is associated with local intolerance, the purpose of this work was to determine the local tolerability of a new progesterone microsphere suspension, administered by intramuscular injection. Methods: An observational, longitudinal, prospective, analytical, multicenter, active pharmacovigilance study was conducted. Two hundred and seven progesterone microsphere administrations were evaluated. Patients evaluated pain, burning sensation, pruritus and dysesthesia. Physicians evaluated erythema, pallor, petechia, ecchymosis, bleeding, edema, induration, abscess, macule, papule, vesicle and pustule. Local tolerability was evaluated using a visual analog scale (100-mm line) on the day of administration, and subsequently on days 3 and 7. Local symptoms were evaluated by patients and local signs by the attending physicians. Results: On the day of application, 68.4% of the administered doses were associated with ‘absent’ or ‘mild’ pain, rising to 91.2% on the 7th day; 83.0% of doses were associated with ‘absence’ of or a ‘mild’ burning sensation on the day of administration, rising to 99.5% on day 7. On administration day, 13.2% reported ‘mild’ erythema and 1.0% ‘moderate’ erythema, and 3.9% of doses had ‘mild’ induration and 0.5% ‘moderate’ induration, which increased to 16.6 and 2.9% on day 3, respectively. The values for pallor, ecchymosis, bleeding, edema and pustule were lower than 10 mm (of 100 mm) on the application day and behaved similarly in subsequent days. There were no reports of petechia, abscess, macule, papule or vesicle with the dose application. Conclusions: Progesterone microspheres were well tolerated without serious or unexpected adverse effects.

Tolerability

Erythema

Ecchymosis

Papule

myalgia

Intravaginal administration

10.1159/000330711

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Citations (6)

Front & Back Matter

Gynecologic and Obstetric Investigation (2012)

Yoichiro Akahori Hisashi Masuyama Yuji Hiramatsu G. Migliaretti Francesco Deltetto

10.1159/000337917

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Niveles séricos de interleucina 15, óxido nítrico e insulina en pacientes con infección crónica por virus de hepatitis C

Revista Médica MD (2013)

R. Contreras-Omaña M Antonieta Xóchitl García-Samper Roberto Bernardo-Escudero Luis Felipe Montaño‐Estrada

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[Prevalence of non-alcoholic steatohepatitis. Comparative study with diabetic patients].

PubMed (2001)

Raúl Bernal-Reyes Alberto Sáenz-Labra Roberto Bernardo-Escudero

Steatohepatitis

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Improvement of quality of life and menopausal symptoms in climacteric women treated with low-dose monthly parenteral formulations of non-polymeric microspheres of 17β-estradiol/progesterone

Gynecological Endocrinology (2016)

Manuel Cortés‐Bonilla Rosalba Alonso-Campero Roberto Bernardo-Escudero María Teresa de Jesús Francisco-Doce Juan Chavarín-González

To evaluate the short term effect over menopausal symptoms and quality of life (QoL) of monthly parenteral formulations of 17β-estradiol (E)/progesterone (P) non-polymeric microspheres.This is a secondary analysis of a multicenter, randomized, single-blinded study that included peri- and post-menopausal symptomatic women assigned to receive a monthly intramuscular injection of 0.5 mg E + 15 mg P (Group A, n = 34), 1 mg E + 20 mg P (Group B, n = 24), or 1 mg E + 30 mg P (Group C, n = 26) for 6 months. Intensity of menopausal symptoms was assessed before and after treatment with the Greene Climacteric Scale (GCS) and QoL with the Utian Quality of Life Scale (UQoLS).Menopausal symptoms improved for all groups at six months evidenced by lower cluster/sub-cluster GCS scores. Equally, there was an overall trend for QoL improvement for all groups evidenced by higher domain UQoLS scores at six months; but only significant for the emotional (Groups A and B) and occupational domains (Groups A and C).The three low-dose continuous sequential intramuscular monthly formulations of E/P microspheres exerted a positive effect over menopausal symptoms and QoL. Long-term research is warranted with these formulations.Clinicaltrials.gov Identifiers NCT 00775242.

Climacteric

10.1080/09513590.2016.1183628

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Citations (6)

Treatment of menopausal symptoms with three low-dose continuous sequential 17β-estradiol/progesterone parenteral monthly formulations using novel non-polymeric microsphere technology

Gynecological Endocrinology (2015)

Manuel Cortés‐Bonilla Roberto Bernardo-Escudero Rosalba Alonso-Campero María Teresa de Jesús Francisco-Doce Marcelino Hernández-Valencia

To analyze the short-term efficacy and safety over menopausal symptoms of three low-dose continuous sequential 17β-estradiol (E)/progesterone (P) parental monthly formulations using novel non-polymeric microspheres.This was a multicenter, randomized, single blinded study in which peri- and postmenopausal women were assigned to receive a monthly intramuscular injection of 0.5 mg E + 15 mg P (Group A, n = 34), 1 mg E + 20 mg P (Group B, n = 24) or 1 mg E + 30 mg P (Group C, n = 26) for 6 months. Primary efficacy endpoints included mean change in the frequency and severity of hot flushes and the effect over urogenital atrophy symptoms at 3 and 6 months. Safety variables included changes in the rate of amenorrhea, endometrial thickness and histopathology, and local and systemic adverse events.Compared to baseline at month 6, the three treatment schemes significantly decreased the rate of urogenital atrophy symptoms and the frequency (mean number per day) and severity (mean number graded as moderate and severe per month) of hot flushes. No differences in studied efficacy parameters were observed between studied groups at baseline or at the end of the study. For all groups the most frequent adverse event was pain at the injection site; however they were all rated as mild. At the end of the study peri- and postmenopausal women displayed no significant changes in endometrial thickness or histopathology in all treated groups. The rate of amenorrhea at the end of the study decreased for all studied groups yet was less evident among postmenopausal women as compared to perimenopausal ones.The three low-dose continuous sequential intramuscular monthly treatments of E/P using novel microsphere technology were effective at reducing menopausal symptoms at short-term with a low rate of adverse events. More long-term and comparative research is warranted to support our positive findings.

Histopathology

Group B

10.3109/09513590.2015.1019853

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Citations (9)

Comparison of the pharmacokinetics of a new 30 mg modified-release tablet formulation of metoclopramide for once-a-day administration versus 10 mg immediate-release tablets: a single and multiple-dose, randomized, open-label, parallel study in healthy male subjects

European Journal of Drug Metabolism and Pharmacokinetics (2012)

Roberto Bernardo-Escudero Rosalba Alonso-Campero María Teresa de Jesús Francisco-Doce Myriam Cortés-Fuentes Miriam Villa-Vargas

Tolerability

Metoclopramide

10.1007/s13318-012-0082-0

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Citations (1)